Ferinject® Assessment in Patients With IRon Deficiency and Chronic Heart Failure (FAIR-HF)

This study has been completed.
Sponsor:
Collaborators:
INC Research
ClinStar
Information provided by:
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT00520780
First received: August 24, 2007
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Condition Intervention Phase
Chronic Heart Failure
Iron Deficiency
Iron Deficiency Anemia
Anaemia
Drug: Ferinject ® (Ferric carboxymaltose)
Drug: Normal saline (0.9%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability [ Time Frame: 24 weeks ]

Enrollment: 456
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ferinject ® (Ferric carboxymaltose)

Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.

After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).

Placebo Comparator: 2 Drug: Normal saline (0.9%)
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
  • Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
  • Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
  • Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

  • History of acquired iron overload.
  • Known active infection, clinically significant bleeding, active malignancy.
  • Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
  • Anaemia due to reasons other than iron deficiency
  • Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
  • History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
  • Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
  • Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
  • Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520780

  Show 48 Study Locations
Sponsors and Collaborators
Vifor Inc.
INC Research
ClinStar
Investigators
Principal Investigator: Philip A Poole-Wilson, MD FRCP National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
  More Information

No publications provided by Vifor Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00520780     History of Changes
Other Study ID Numbers: FER-CARS-02
Study First Received: August 24, 2007
Last Updated: October 15, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Drug Organization.
Italy: National Institute of Health ("Istituto Superiore di Sanità - I.S.S.")
Italy: The Italian Medicines Agency ("Agenzia Italiana del Farmaco - A.I.F.A.")
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agenc

Keywords provided by Vifor Inc.:
Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Anaemia
Heart disease

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Iron
Heart Failure
Cardiovascular Diseases
Heart Diseases
Hematologic Diseases
Malnutrition
Metabolic Diseases
Nutrition Disorders
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014